Customised Disposables Systems

1. Design

To eliminate design error and minimise your time constraints, the BioSelector will ensure you have complete control over your tubing manifold design.

2. Drawings

The BioSelector tool allows you to design a virtual disposable manifold from a large inventory of parts, which then generates a unique technical drawing.

3. Assembly

With the drawing, your manifold is assembled in a Class C (Class 10,00) clean room by our highly experienced technicans.

4. Packaging

The manifold is pouched, labelled for audit, boxed in a plactic carton, then wrapped in a polythene sheath prior to transport. This eliminates particulate ingress to your GMP facility.

5. Documents

All items are labelled, with peelable copies for your BMRs. Each manifold is accompanied by a portfolio containing component conformances, batch assembly data, and gamma sterilisation data.

6. Sterilisation

The boxed carton of your manifolds is sterilised by gamma irradiation 25 to 40 kiloGrays and then couriered to you anywhere in the world.

7. Quality Control

Manifold components are made from USP Class VI polymers. BioPure components are pyrogen free; silicone is platinum cured and leach tested. Devices are assembled to eliminate particulates.

8. Quality Assurance

BioPure can partner customers to determine:

• Gamma maps
• Sterile testing
• MEM elution test
• Leachables

BioPure can:

Dispatch manifolds within two weeks of an agreed drawing

Custom build to any size: 10 to 10,000 litres

Provide GMP support documents

Partner your QA/QC requirements

Provide a DMF audit portfolio